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Record W2161021913 · doi:10.3324/haematol.2014.115840

Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I

2015· article· en· W2161021913 on OpenAlexafffund
Srđan Verstovšek, Ruben A. Mesa, Jason Gotlib, R. S. Levy, Vikas Gupta, John F. DiPersio, John Catalano, Michael W. Deininger, Carole B. Miller, Richard T. Silver, Moshe Talpaz, E. Winton, Jimmie H. Harvey, Murat O. Arcasoy, Elizabeth O. Hexner, Roger M. Lyons, Azra Raza, Kris Vaddi, William Sun, Wei Peng, V. Sandor, Hagop M. Kantarjian

Bibliographic record

VenueHaematologica · 2015
Typearticle
Languageen
FieldMedicine
TopicMyeloproliferative Neoplasms: Diagnosis and Treatment
Canadian institutionsPrincess Margaret Cancer CentreUniversity of Toronto
FundersStanford Cancer InstituteNational Heart, Lung, and Blood InstituteUniversity of Texas MD Anderson Cancer CenterWeill Cornell Medical CollegeUniversity of California, Los AngelesMonash UniversityHollings Cancer Center, Medical University of South CarolinaNorthwestern UniversityIncyteNIH Clinical CenterTownsville Hospital and Health ServiceEmory UniversityHuntsman Cancer InstituteUniversity of TorontoTower Cancer Research FoundationLondon Health Sciences CentreBarbara Ann Karmanos Cancer InstituteRush UniversityUniversity of LouisvilleGeorgetown UniversityNational Cancer InstituteWake Forest UniversityKaiser PermanenteCleveland ClinicGeorge Washington UniversityUniversity of PennsylvaniaVanderbilt UniversityUniversity of Southern CaliforniaPark Nicollet Foundation
KeywordsRuxolitinibMyelofibrosisMedicineInternal medicineOncologySurgeryBone marrow

Abstract

fetched live from OpenAlex

In the phase III COMFORT-I study, the Janus kinase 1 (JAK1)/JAK2 inhibitor ruxolitinib provided significant improvements in splenomegaly, key symptoms, and quality-of-life measures and was associated with an overall survival benefit relative to placebo in patients with intermediate-2 or high-risk myelofibrosis. This planned analysis assessed the long-term efficacy and safety of ruxolitinib at a median follow-up of 149 weeks. At data cutoff, approximately 50% of patients originally randomized to ruxolitinib remained on treatment whereas all patients originally assigned to placebo had discontinued or crossed over to ruxolitinib. At week 144, mean spleen volume reduction was 34% with ruxolitinib. Previously observed improvements in quality-of-life measures were sustained with longer-term ruxolitinib therapy. Overall survival continued to favor ruxolitinib despite the majority of placebo patients crossing over to ruxolitinib [hazard ratio 0.69 (95% confidence interval: 0.46-1.03); P = 0.067]. Exploratory analyses suggest that crossover may have contributed to an underestimation of the true survival difference between the treatment groups. Ruxolitinib continued to be generally well tolerated; there was no pattern of worsening grade ≥ 3 anemia or thrombocytopenia with longer-term ruxolitinib exposure. These longer-term data continue to support the efficacy and safety of ruxolitinib in patients with myelofibrosis. The study is registered at clinicaltrials.gov: NCT00952289.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.005
metaresearch head score (Gemma)0.003
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Non-randomized trial · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.005
Threshold uncertainty score0.024

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0050.003
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.002
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0010.001
Open science0.0000.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0010.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.026
GPT teacher head0.256
Teacher spread0.230 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNon-randomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations329
Published2015
Admission routes2
Has abstractyes

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